UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006919 |
|---|---|
| Receipt number | R000008153 |
| Scientific Title | Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion |
| Date of disclosure of the study information | 2011/12/25 |
| Last modified on | 2013/03/28 19:03:40 |
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Basic information
Public title
Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion
Acronym
SAVE-ISLET
Scientific Title
Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion
Scientific Title:Acronym
SAVE-ISLET
Region
| Japan |
Condition
Condition
Type 1 diabetes with residual insulin secretion (Slowly Progressive Insulin-Dependent Diabetes millitus, Latent Autoimmune Diabetes in Adults)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to investigate the effect of liraglutide, an once-daily injection long-acting GLP-1 receptor agonist, on beta-cell mass and function as well as glycemic control in patients with type 1 diabetes with residual insulin secretion by open-labeled, randomized control manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in insulin secretory response to glucagon- and arginine-stimulation test
Key secondary outcomes
Anti GADAb, Glycemic control(HbA1c, FPG/PPG, 7 points blood glucose levels in self-monitoring of blood glucose, Body weight, Hypoglycemia, Total dose of insulin injection per day, Adverse Events (including an abnormal laboratory finding)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Liraglutide group
Additional administration of Liraglutide injection 0.6-0.9mg per day on ongoing insulin therapy (dose of insulin can be changed) for 56 weeks
Interventions/Control_2
Insulin group (Control)
Continue of ongoing insulin injection
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients who have agreed to participate in this study with an informed consent
2. HbA1c <9.0%, FPG <200mg/dl, Casual PG <350mg/dl at visit 1
3. Positive for any autoimmune antibody to pancreas (GADAb, IA-2Ab)
4. Diagnosed as SPIDDM (LADA) with residual beta-cell function (C-peptide & >0.3ng/ml)
Key exclusion criteria
1. The patients who did not agree with this study
2. The patients with serious complications
3. The patients with chronic kidney disease higher than stage 4
4. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
06-6312-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北野病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2013 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008153
